Inclusion Criteria:

- Historically confirmed advanced NSCLC stages IIIB or IV

- Exon 19 deletion or exon 21 activating mutation in EGFR

- EGFR mutation status must be confirmed for participation in the study. EGFR can be
performed either by central or local laboratory. If analysis is done locally,
verifiable documentation confirming the EGFR mutation status must be submitted for
review and approval by sponsor prior to randomization. If no local result is
available, formalin-fixed, paraffin-embedded archival tissue representative of the
tumor or, in the absence of archival tissue, a fresh tumor tissue sample of
sufficient size to perform EGFR mutation analysis must be submitted centrally.
Results of the central analysis must be available prior to randomization.
Additionally, subjects should provide tissue blocks for biomarker central analysis
whenever possible. Ideal tissue requirement: block with ≥5 mm2 tumor area sufficient
to provide four 4-micron, and five 10-micron sections

- Measurable disease according to RECIST (version 1.1)

- ECOG performance status 0-1

- Must be able to take oral medication

- Fasting glucose <= 150 mg/dL (8.3 mmol/L). Concurrent use of non-insulinotropic anti
hyperglycemic therapy is permitted if the dose has been stable for >= 4 weeks at the
time of randomization

- Adequate hematopoietic, hepatic, and renal function as follows:

- Neutrophil count >= 1500/uL

- Platelet count >= 100,000/uL

- Serum creatinine <= 1.5 x Upper Limit of Normal (ULN)

- Potassium, magnesium, and calcium within normal limits (supplementation and
re-testing is permitted)

- Patients - both male and female - with reproductive potential (ie, menopausal for
less than 1 year and not surgically sterilized) must agree to practice effective
contraceptive measure throughout the study. Women of childbearing potential must
provide a negative pregnancy test (serum or urine) within 14 days prior to
randomization. Men must agree not to donate sperm while on study drug and up to 90
days following the last dose of study drug

- Patients must provide written informed consent to participate in the study

- Patients may not have received chemotherapy for advanced NSCLC. Previous adjuvant
and/or neoadjuvant treatment for NSCLC is permitted

- Prior radiation therapy is permitted provided patients have recovered from the acute,
toxic effects of radiotherapy prior to randomization. A minimum of 28 days must have
elapsed between the end of radiotherapy and randomization

- Prior surgery is permitted provided that the surgery was done >= 28 days prior to
randomization and adequate wound healing has occurred prior to randomization

- Use of drugs that have a known risk of causing Torsades de Pointes (TdP) ('Torsades
List' on www.azcert.org/medical-pros/drug-lists/bycategory.cfm) are prohibited within
14 days prior to randomization

- Use of strong/moderate CYP1A2 inhibitors such as ciprofloxacin and fluvoxamine. Other
less potent CYP1A2 inhibitors/inducers are not excluded

- Use of strong/moderate CYP3A4 inhibitors and inducers

- History of cerebrovascular accident (CVA) within 6 months prior to randomization or
that resulted in ongoing neurologic instability

- History of any psychiatric or neurologic condition that might impair the patient's
ability to understand or to comply with the requirements of the study or to provide
informed consent

- Pregnant or breast-feeding females

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to the study drug

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